Details for New Drug Application (NDA): 209241
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The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
Summary for 209241
Tradename: | INGREZZA |
Applicant: | Neurocrine |
Ingredient: | valbenazine tosylate |
Patents: | 22 |
Pharmacology for NDA: 209241
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 209241
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1060 | 70370-1060-1 | 30 CAPSULE in 1 BOTTLE (70370-1060-1) |
INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1080 | 70370-1080-1 | 30 CAPSULE in 1 BOTTLE (70370-1080-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Apr 11, 2017 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 18, 2030 | ||||||||
Regulatory Exclusivity Use: | FOR TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE | ||||||||
Regulatory Exclusivity Expiration: | Aug 18, 2026 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE | ||||||||
Patent: | 10,065,952 | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | A METHOD OF TREATING HUNTINGTON'S CHOREA |
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